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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated.
Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure
As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| change from tenofovir to raltegravir | Other | Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| change from tenofovir to raltegravir | Drug | Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Reduced or Resolved Proteinuria | Measurement of Protein in Urine samples at end of study visit | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Without HIV Re-bound | HIV Viral load blood test at week 24 | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fritz Bredeek, MD | Metropolis Medical | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Change From Tenofovir to Raltegravir | Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
HIV
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| ID | Title | Description |
|---|---|---|
| BG000 | Change From Tenofovir to Raltegravir | Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Reduced or Resolved Proteinuria | Measurement of Protein in Urine samples at end of study visit | Posted | Number | participants | 24 weeks |
|
|
during the study and 4 weeks after end of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Change From Tenofovir to Raltegravir | Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fritz Bredeek | Metropolis Medical | 415 292 5477 | fritz@doctor.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D011507 | Proteinuria |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Patients Without HIV Re-bound | HIV Viral load blood test at week 24 | Subjects entered with undetectable Viral Load and Proteinuria | Posted | Number | participants | 24 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012897 | Slow Virus Diseases |